BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15.5F X 24CM DURA-FLOW CATHETER

    MDR report key: 1930142 · Received November 18, 2010

    Report

    Report Number
    2518902-2010-00073
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LEAKED NEAR THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15.5F X 24CM DURA-FLOW CATHETER HEMODIALYSIS CATHETER MSD MEDCOMP 10301201 MAPT110

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention